Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams (PREPODOT)
Primary Purpose
Postoperative Delirium, Aging Disorder
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Occupational therapy intervention
Standard non-pharmacological prevention intervention
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Delirium focused on measuring Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium
Eligibility Criteria
Inclusion Criteria:
- Hospital admission for highly complex elective surgery
Exclusion Criteria:
- History of cognitive impairment.
- A low score in Mini-Mental State Examination (MMSE): <23 points if the patient has 6 or more years of schooling, and <18 points if the patient has <6 years of schooling.
- Severe communication disorder and cultural language limitation (language other than Spanish).
- Delirium on admission or prior to the start of the intervention (measured with CAM).
- Patient enrolled in another study
Sites / Locations
- Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Standard non-pharmacological intervention during 5 days after surgery.
Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery.
Outcomes
Primary Outcome Measures
Delirium
Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Subsyndromal delirium
Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)
Secondary Outcome Measures
Lenght of hospital stay
Number of days between admission and discharge to the hospital
Mortality
Percentage of patients who die between the day of surgery and 30 days after surgery
Severity of delirium
Severity of delirium will be evaluated with questionnaire CAM-S
Duration of delirium
Number of days in which the patients have delirium
Full Information
NCT ID
NCT03704090
First Posted
October 7, 2018
Last Updated
April 26, 2021
Sponsor
University of Chile
Collaborators
Hospital de San Jose, Comisión Nacional de Investigación Científica y Tecnológica
1. Study Identification
Unique Protocol Identification Number
NCT03704090
Brief Title
Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams
Acronym
PREPODOT
Official Title
Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams in Patients Older Than 75 Years Undergoing High-risk Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Hospital de San Jose, Comisión Nacional de Investigación Científica y Tecnológica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs.
Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD.
The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries.
The hypothesis is that the application of these measures decreases the incidence of delirium in this population.
Detailed Description
To determine whether non-pharmacological measures decrease the incidence of POD during the perioperative period in elderly patients undergoing highly complex elective surgeries, it will be performed a randomized clinical trial, where two groups of patients older than 75 years undergoing highly complex elective surgeries will be compared:
The first group will receive a protocol of non-pharmacological interventions implemented by occupational therapy teams to prevent delirium plus standard non-pharmacological prevention interventions.
The second group will only receive standard non-pharmacological prevention interventions.
This study will be carried out in the surgical units of the Hospital Clinico de la Universidad de Chile (HCUCH) and in the Hospital San Jose (HSJ).
The expected result is to demonstrate that the interventions carried out by occupational therapists decrease the incidence of DPO in a significant way in comparison with standard prevention intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, Aging Disorder
Keywords
Postoperative Delirium, Prevention Measure, Non-pharmacological, Subsyndromal Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Elderly patients who will undergo major surgery will be randomized to 2 prevention groups of postoperative delirium:
Control: standard non-pharmacological prevention measures for 5 days after surgery.
Intervention: occupational therapist plus standard non-pharmacological prevention measures for 5 days after surgery.
Masking
Care ProviderInvestigator
Masking Description
Patients were randomized in 16 blocks of 10 patients and only one investigator has the randomized information. This researcher will not have any role in the recruitment, intervention, and diagnosis of postoperative delirium. Also, the analysis of data will be performed by researchers who will be masked to the randomization information.
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard non-pharmacological intervention during 5 days after surgery.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery.
Intervention Type
Behavioral
Intervention Name(s)
Occupational therapy intervention
Intervention Description
Prevention of postoperative delirium by occupational therapy intervention
Intervention Type
Behavioral
Intervention Name(s)
Standard non-pharmacological prevention intervention
Intervention Description
Prevention of postoperative delirium using standard non-pharmacological prevention measures
Primary Outcome Measure Information:
Title
Delirium
Description
Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic)
Time Frame
5 days
Title
Subsyndromal delirium
Description
Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Lenght of hospital stay
Description
Number of days between admission and discharge to the hospital
Time Frame
30 days
Title
Mortality
Description
Percentage of patients who die between the day of surgery and 30 days after surgery
Time Frame
30 days
Title
Severity of delirium
Description
Severity of delirium will be evaluated with questionnaire CAM-S
Time Frame
5 days
Title
Duration of delirium
Description
Number of days in which the patients have delirium
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospital admission for highly complex elective surgery
Exclusion Criteria:
History of cognitive impairment.
A low score in Mini-Mental State Examination (MMSE): <23 points if the patient has 6 or more years of schooling, and <18 points if the patient has <6 years of schooling.
Severe communication disorder and cultural language limitation (language other than Spanish).
Delirium on admission or prior to the start of the intervention (measured with CAM).
Patient enrolled in another study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonello Penna, MD/PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evelyn Alvarez, TO/MSc
Organizational Affiliation
Universidad Central/Universidad de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Constanza Briceño, TO/MSc
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Tobar, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Salech, MD/PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela Ponce, Ing
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veronica Rojas, Nurse/MSc
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gonzalo Navarrete, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7690306
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27660922
Citation
Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.
Results Reference
result
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Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams
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